NCT05296447

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.

Conditions

• Diabetic Retinopathy, DR

Interventions

Type	Name	Description
OTHER	No Intervention	All subjects that previously received RGX-314 in a parent study

Timeline

• Start date: 2022-04-04
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2022-03-25
• Last updated: 2025-06-18

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study